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Accuracy Performance Verification of the INVOS™ System in Pediatrics

NCT05962905 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-05-09

No results posted yet for this study

Summary

Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.

Conditions

  • Cerebral Oxygenation
  • Pediatric ALL

Interventions

OTHER

Blood sample

During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization

DEVICE

INVOS monitoring

During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Ami R Stuart, PhD · Principal Clinical Research Specialist

Eligibility

Min Age
0 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2024-11-30
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962905 on ClinicalTrials.gov